MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7120Q/58

Device Problems Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Capturing Problem (2891)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  Injury  

Event Description

It was reported that high capture threshold was observed on the right ventricular (rv) lead.An attempt was made to reposition the rv lead, however, the helix was unable to be retracted or extended.The rv lead was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported event of inadequate capture was not confirmed and the reported event of helix mechanism was confirmed.As received, a complete lead with a stylet and an implant tool was returned in one piece for analysis.Electrical testing was performed and revealed no indication of conductor fractures or internal shorts.A visual inspection of the lead revealed the helix was in the extended position and clogged with blood and tissue.An x-ray examination was performed and revealed no anomalies to the lead body.The inner coil was over-torqued during the helix mechanism and extension length test.After cleaning, the helix was able to be successfully extended and retracted when torque was applied directly to the inner coil.The measured full helix extension length was within required product performance specification.The cause of the reported event of helix mechanism issue was isolated to the helix being clogged with blood and tissue.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16897389
• MDR Text Key: 314853319
• Report Number: 2017865-2023-19534
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502818
• UDI-Public: 05414734502818
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 7120Q/58
• Device Catalogue Number: 7120Q-58
• Device Lot Number: A000093561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention